RU2014133818A - Стабилизированный состав pth - Google Patents

Стабилизированный состав pth Download PDF

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Publication number
RU2014133818A
RU2014133818A RU2014133818A RU2014133818A RU2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A RU 2014133818 A RU2014133818 A RU 2014133818A
Authority
RU
Russia
Prior art keywords
pharmaceutical composition
mannitol
stabilizer
lactate
parenteral administration
Prior art date
Application number
RU2014133818A
Other languages
English (en)
Russian (ru)
Inventor
Ваибхав Дньянешвар ДЕОКАР
Анджали Деепак Апте-Дешпанде
Шеетал Арвинд РАУТ
Баладжи ДАМОДАРАН
Сайрус КАРКАРИА
Original Assignee
Люпин Лимитед
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Люпин Лимитед filed Critical Люпин Лимитед
Publication of RU2014133818A publication Critical patent/RU2014133818A/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
RU2014133818A 2012-01-20 2013-01-19 Стабилизированный состав pth RU2014133818A (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN53/KOL/2012 2012-01-20
IN53KO2012 2012-01-20
PCT/IB2013/050503 WO2013108235A1 (en) 2012-01-20 2013-01-19 Stabilized pth formulation

Publications (1)

Publication Number Publication Date
RU2014133818A true RU2014133818A (ru) 2016-03-20

Family

ID=47714479

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2014133818A RU2014133818A (ru) 2012-01-20 2013-01-19 Стабилизированный состав pth

Country Status (12)

Country Link
US (1) US20150011473A1 (OSRAM)
EP (1) EP2804622A1 (OSRAM)
JP (1) JP2015504087A (OSRAM)
AU (1) AU2013210689A1 (OSRAM)
BR (1) BR112014017424A8 (OSRAM)
CA (1) CA2862776A1 (OSRAM)
IN (1) IN2014MN01470A (OSRAM)
MX (1) MX2014008668A (OSRAM)
PH (1) PH12014501658A1 (OSRAM)
RU (1) RU2014133818A (OSRAM)
WO (1) WO2013108235A1 (OSRAM)
ZA (1) ZA201404918B (OSRAM)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018009938A (es) 2016-03-01 2019-03-14 Ascendis Pharma Bone Diseases As Profarmacos de hormona paratiroidea (pth).
MX2019003181A (es) 2016-09-29 2019-08-05 Ascendis Pharma Bone Diseases As Regimen de dosificacion para un compuesto de hormona paratiroidea (pth) de liberacion controlada.
GB201706781D0 (en) 2017-04-28 2017-06-14 Univ Sheffield Parathyroid hormone fusion polypeptide
WO2019059303A1 (ja) 2017-09-22 2019-03-28 旭化成ファーマ株式会社 薬物動態及び/又は安全性に優れるテリパラチド含有液状医薬組成物
CN110996988A (zh) * 2017-09-22 2020-04-10 旭化成制药株式会社 稳定性优异的含有特立帕肽的液态药物组合物
JP2019060866A (ja) * 2017-09-22 2019-04-18 旭化成ファーマ株式会社 液状医薬組成物の体内動態を予測する方法
JP2019156805A (ja) * 2018-03-16 2019-09-19 ナガセ医薬品株式会社 容器充填ヒトpth(1−34)液体医薬組成物及びその製造方法
CN112638407A (zh) * 2018-07-30 2021-04-09 夏尔-Nps医药品有限公司 重组人类甲状旁腺素的改进稳定性调配物
BR112021014581A2 (pt) * 2019-02-11 2021-12-14 Ascendis Pharma Bone Diseases As Formulações farmacêuticas líquidas de conjugados de pth
CN110917150A (zh) * 2019-12-31 2020-03-27 北京博康健基因科技有限公司 一种pth冻干制剂及其制备方法
EP4110370A4 (en) * 2020-03-30 2023-06-07 Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. HUMAN PARATHYROID HORMONE (PTH) FORMULATIONS AND METHODS OF PRODUCING THEM
JP6947946B1 (ja) * 2020-05-11 2021-10-13 旭化成ファーマ株式会社 テリパラチド又はその塩を含有する安定な液状医薬製剤
WO2021229835A1 (ja) * 2020-05-11 2021-11-18 旭化成ファーマ株式会社 テリパラチド又はその塩を含有する安定な液状医薬製剤
TWI888383B (zh) * 2020-06-19 2025-07-01 丹麥商阿森迪斯藥物骨疾病股份有限公司 Pth綴合物的液體藥物製劑

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6770623B1 (en) 1997-12-09 2004-08-03 Eli Lilly And Company Stabilized teriparatide solutions
US20030059376A1 (en) * 1999-06-04 2003-03-27 Libbey Miles A. Formulations comprising dehydrated particles of pharmaceutical agents and process for preparing the same
WO2006022301A1 (ja) * 2004-08-24 2006-03-02 Daiichi Asubio Pharma Co., Ltd. 生理活性ペプチド液状製剤
KR100700869B1 (ko) 2005-06-03 2007-03-29 재단법인 목암생명공학연구소 Pth, 완충제 및 안정제를 포함하는 안정한 pth조성물
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins

Also Published As

Publication number Publication date
JP2015504087A (ja) 2015-02-05
CA2862776A1 (en) 2013-07-25
MX2014008668A (es) 2014-10-06
BR112014017424A2 (pt) 2017-06-13
PH12014501658A1 (en) 2014-10-13
AU2013210689A1 (en) 2014-07-31
EP2804622A1 (en) 2014-11-26
US20150011473A1 (en) 2015-01-08
IN2014MN01470A (OSRAM) 2015-04-17
ZA201404918B (en) 2016-01-27
BR112014017424A8 (pt) 2017-07-04
WO2013108235A1 (en) 2013-07-25

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